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ApoVax™
ApoVax™ is a recombinant protein-based vaccine. The first family of the ApoVax™ products is the ApoVax104™ vaccine line. In preclinical studies, the vaccine has proven to be much more effective and less toxic than other vaccine components currently being tested in late stage clinical trials by large pharmaceutical companies.
The technology involves an immunoregulatory protein and an antigen which is a tumor or infectious disease marker that stimulates an immune response. The immunoregulatory protein is a chimeric protein made up of two different proteins; a protein called streptavidin, and a portion of the immunoregulatory protein 4-1BB ligand (4-1BBL). The presence of streptavidin allows for 1) the formation of a tetrameric immunoprotein able to crosslink its receptor, 4-1BB, on immune cells for potent signal transduction, and 2) the rapid attachment of biotinylated antigens which form the immunoreactive component of the vaccine.
The ApoVax™ technology is being applied to cancer and infectious diseases enabling the creation of disease-specific vaccines that have clinical utility in a multitude of diseases representing many multi-billion dollar markets. The flexibility of the ApoVax104™ technology is demonstrated in the following table:
ApoImmune has licensed a component of its ApoVax104™ vaccine line from Amgen, Inc., which management believes provides the Company freedom to practice the ApoVax104™ platform. The Company's first product will be a therapeutic vaccine for treating cervical cancer and human papillomavirus (HPV) infection in women using the ApoVax104-HPV™ technology. A Phase I clinical trial is expected to begin in Q3 2009.
ApoVax104™ Competitive Advantage
An ApoVax104-Ag™ vaccine consists of an antigen attached to the proprietary ApoVax104™ protein. When administered into the body, ApoVax104™ directs the antigen to specialized immune cells whose main function is to process antigen material and present it to other cells of the immune system, thereby activating an immune response. These specialized cells are called dendritic cells.
Delivery of the antigen to the dendritic cells by ApoVax104™ results in a cascade of immune responses that leads to activation of the body's cellular and humoral immune system to attack and kill cells involved in tumor growth and infectious disease proliferation. ApoVax104™ can be used against any type of cancer or infectious disease with a known antigen or antigens.
The ApoVax104™ vaccine platform has a unique mechanism of action not shared by any other vaccines on the market or in clinical trials which may make it the first therapeutic cancer vaccine to translate effectively into the clinic. What sets ApoVax104™ apart from other vaccines is that it not only activates both the innate (non-specific) and adaptive (specific) arms of the immune system, it overcomes immune evasion strategies used by tumors and chronic infections to survive in the body. ApoVax104™ overcomes these evasion strategies by inhibiting a specific set of immune cells called T regulatory cells.
In tumors, T regulatory cells are employed to shut down normal immune defenses in the tumor microenvironment thereby creating an immunosuppressive environment and evading the immune system. Because of their dominant role in tumor immune evasion mechanisms, T regulatory cells are an ideal target for therapeutic purposes. In fact, the challenge for therapeutic vaccines for HPV-associated disease has been reversing the immunologically suppressive microenvironment caused by T regulatory cells which dominate the cervical lesions and abolish the killer T cell defense response. By doing so the cytotoxic killer T cells are denied access to the infected and neoplastic cells.
A cancer vaccine that disrupts T regulatory suppression in combination with immune activation, like ApoVax104™, presents an important therapeutic approach with a greater likelihood of success in the clinic. Preclinical studies and clinical trials testing T regulatory cell depletion or abrogation of their suppressive function improve anti-tumor immunity and show promise for novel therapeutic vaccines.
Competitors in the cancer market are companies using immunotherapies which are often time consuming, complicated to perform, and/or generally inefficient. ApoVax104™ has a strong competitive advantage over these therapies as it efficiently activates both the innate and adaptive arms of the immune system, overcomes immune evasion strategies used by cancers, is easily manufactured and modified for different cancers, and is readily stored and administered.
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